Systems and methods for delivering a fluid to a patient with reduced contamination

ABSTRACT

An apparatus includes a cannula assembly, a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing includes an inlet port removably coupled to the cannula assembly and defines an inner volume. The fluid reservoir is fluidically coupled to the housing and configured to receive and isolate a volume of bodily fluid from a patient. The flow control mechanism is at least partially disposed in the inner volume. The actuator is operably coupled to the flow control mechanism and is configured to move the flow control mechanism between a first configuration, in which bodily fluid can flow, via a fluid flow path defined by the flow control mechanism, from the cannula assembly, through the inlet port and into the fluid reservoir, to a second configuration, in which the fluid reservoir is fluidically isolated from the cannula assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/049,326, filed Oct. 9, 2013, entitled, “Systems and Methods forDelivering a Fluid to a Patient with Reduced Contamination,” whichclaims priority to and the benefit of U.S. Provisional PatentApplication Ser. No. 61/712,468, filed Oct. 11, 2012, entitled, “Systemsand Methods for Delivering a Fluid to a Patient with ReducedContamination,” the disclosures of which are incorporated herein byreference in their entirety.

BACKGROUND

Embodiments described herein relate generally to delivering a fluid to apatient, and more particularly to devices and methods for delivering aparenteral fluid to a patient with reduced contamination from microbesor other contaminants exterior to the body and/or the fluid source, suchas dermally residing microbes.

Human skin is normally habituated in variable small amounts by certainbacteria such as coagulase-negative Staphylococcus species,Proprionobacterium acnes, Micrococcus species, Streptococci Viridansgroup, Corynebacterium species, and Bacillus species. These bacteria forthe most part live in a symbiotic relationship with human skin but insome circumstances can give rise to serious infections in the bloodstream known as septicemia. Septicemia due to these skin residingorganisms is most often associated with an internal nidus of bacterialgrowth at the site of injured tissue, for example a damaged, scarredheart valve, or a foreign body (often an artificial joint, vessel, orvalve). Furthermore, there are predisposing factors to these infectionssuch as malignancy, immunosuppression, diabetes mellitus, obesity,rheumatoid arthritis, psoriasis, and advanced age. In some instances,these infections can cause serious illness and/or death. Moreover, theseinfections can be very expensive and difficult to treat and often can beassociated with medical related legal issues.

In general medical practice, blood is drawn from veins (phlebotomy) fortwo main purposes; (1) donor blood in volumes of approximately 500 mL isobtained for the treatment of anemia, deficient blood clotting factorsincluding platelets and other medical conditions; and (2) smallervolumes (e.g., from a few drops to 10 mL or more) of blood are obtainedfor testing purposes. In each case, whether for donor or testingspecimens, a fluid communicator (e.g., catheter, cannula, needle, etc.)is used to penetrate and enter a vein (known as venipuncture) enablingwithdrawing of blood into a tube or vessel apparatus in the desiredamounts for handling, transport, storage and/or other purposes. The siteof venipuncture, most commonly the antecubital fossa, is prepared bycleansing with antiseptics to prevent the growth of skin residingbacteria in blood withdrawn from the vein. It has been shownvenipuncture needles dislodge fragments of skin including hair and sweatgland structures as well as subcutaneous fat and other adnexalstructures not completely sterilized by skin surface antisepsis. Theseskin fragments can cause septicemia in recipients of donor bloodproducts, false positive blood culture tests and other undesirableoutcomes. Furthermore, methods, procedures and devices are in use, whichdivert the initial portion of venipuncture blood enabling exclusion ofthese skin fragments from the venipuncture specimen in order to preventsepticemia in recipients of donor blood products, false positive bloodculture tests and other undesirable outcomes.

Venipuncture is also the most common method of accessing the bloodstream of a patient to deliver parenteral fluids into the blood streamof patients needing this type of medical treatment. Fluids in containersare allowed to flow into the patient's blood stream through tubingconnected to the venipuncture needle or through a catheter that isplaced into a patient's vasculature (e.g. peripheral IV, central line,etc.). During this process, fragments of incompletely sterilized skincan be delivered into the blood stream with the flow of parenteralfluids and/or at the time of venipuncture for introduction and insertionof a peripheral catheter. These fragments are undesirable in the bloodstream and their introduction into the blood stream of patients (whetherdue to dislodging of fragments by venipuncture needle when inserting acatheter or delivered through tubing attached to needle or catheter) iscontrary to common practices of antisepsis. Further, these microbes canbe associated with a well-known phenomenon of colonization by skinresiding organisms of the tubing and tubing connectors utilized todeliver parenteral fluids. The colonization is not typically indicativeof a true infection but can give rise to false positive blood culturetests, which may result in unnecessary antibiotic treatment, laboratorytests, and replacement of the tubing apparatus with attendant patientrisks and expenses. Furthermore, the risk of clinically significantserious infection due to skin residing organisms is increased.

As such, a need exists for improved fluid transfer devices, catheterintroduction techniques and devices, as well as methods for delivering aparenteral fluid to a patient that reduce microbial contamination andinadvertent injection of undesirable external microbes into a patient'sblood stream.

SUMMARY

Devices and methods for delivering a fluid to a patient and/orintroducing a peripheral catheter with reduced contamination fromdermally residing microbes or other contaminants exterior to the bodyand/or an external fluid source are described herein. In someembodiments, an apparatus includes a cannula assembly, a housing, afluid reservoir, a flow control mechanism, and an actuator. The housinghas a proximal end portion and a distal end portion and defines an innervolume therebetween. The housing includes an inlet port removablycoupled to the cannula assembly. The fluid reservoir is fluidicallycoupled to the housing and configured to receive and isolate a firstvolume of bodily fluid withdrawn from a patient. The flow controlmechanism is at least partially disposed in the inner volume and isconfigured to move relative to the housing between a first configurationand a second configuration. The flow control mechanism defines a fluidflow path between the cannula assembly and the fluid reservoir in thefirst configuration. The actuator is operably coupled to the flowcontrol mechanism to move the flow control mechanism from the firstconfiguration, in which the inlet port is placed in fluid communicationthe fluid reservoir such that bodily fluid can flow from the cannulaassembly, through the inlet port via the fluid flow path and to thefluid reservoir, to the second configuration, in which the fluidreservoir is fluidically isolated from the cannula assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are schematic illustrations of a fluid transfer deviceaccording to an embodiment.

FIG. 3 is a schematic illustration of a fluid transfer device accordingto an embodiment.

FIG. 4 is a perspective view of a fluid transfer device according to anembodiment.

FIG. 5 is an exploded view of the fluid transfer device of FIG. 4.

FIG. 6 is a cross-sectional view of the fluid transfer device takenalong the line X₁-X₁ in FIG. 4, in a first configuration.

FIG. 7 is an enlarged view of a portion of the fluid transfer devicelabeled as region A in FIG. 6.

FIGS. 8 and 9 are cross-sectional views of the fluid transfer devicetaken along the line X₁-X₁ in FIG. 4, in a second and thirdconfiguration, respectively.

FIG. 10 is a side view of the fluid transfer device of FIG. 4 in afourth configuration.

FIG. 11 is a perspective view of a fluid transfer device according to anembodiment.

FIG. 12 is an exploded view of the fluid transfer device of FIG. 11.

FIGS. 13 and 14 are cross-sectional views of the fluid transfer devicetaken along the line X₂-X₂ in FIG. 11, in a first and secondconfiguration, respectively.

FIG. 15 is a side view of the fluid transfer device of FIG. 11 in athird configuration.

FIG. 16 is a perspective view of a fluid transfer device according to anembodiment.

FIG. 17 is an exploded view of the fluid transfer device of FIG. 16.

FIG. 18 is a cross-sectional perspective view of a housing included inthe fluid transfer device taken along the line X₄-X₄ in FIG. 17.

FIG. 19 is a cross-sectional perspective view of a portion of a flowcontrol mechanism included in the fluid transfer device taken along theline X₅-X₅ in FIG. 17.

FIG. 20 is a cross-sectional view of the fluid transfer device takenalong the line X₃-X₃ in FIG. 16, in a first configuration.

FIG. 21 is a front view of the fluid transfer device of FIG. 16 in asecond configuration.

FIG. 22 is a cross-sectional view of the fluid transfer device takenalong the line X₃-X₃ in FIG. 16, in the second configuration.

FIG. 23 is a side view of the fluid transfer device of FIG. 16 in athird configuration.

FIG. 24 is a perspective view of a fluid transfer device according to anembodiment.

FIG. 25 is an exploded view of the fluid transfer device of FIG. 24.

FIG. 26 is a cross-sectional perspective view of a fluid reservoirincluded in the fluid transfer device taken along the line X₇-X₇ in FIG.25.

FIG. 27 is a cross-sectional perspective view of a flow controlmechanism included in the fluid transfer device taken along the lineX₈-X₈ in FIG. 25.

FIGS. 28-30 are cross-sectional views of the fluid transfer device takenalong the line X₆-X₆ in FIG. 24, in a first, second, and thirdconfiguration, respectively.

FIG. 31 is a perspective view of a fluid transfer device according to anembodiment.

FIG. 32 is an exploded view of the fluid transfer device of FIG. 31.

FIGS. 33 and 34 are cross-sectional views of the fluid transfer devicetaken along the line X₉-X₉ in FIG. 31, in a first configuration and asecond configuration, respectively.

FIG. 35 is a perspective view of a fluid transfer device according to anembodiment.

FIG. 36 is an exploded view of the fluid transfer device of FIG. 35.

FIG. 37 is a cross-sectional view of the fluid transfer device takenalong the line X₁₀-X₁₀ in FIG. 35, in a first configuration.

FIG. 38 is a front view of the fluid transfer device of FIG. 35 in asecond configuration.

FIG. 39 is a cross-sectional view of the fluid transfer device takenalong the line X₁₀-X₁₀ in FIG. 35, in the second configuration.

FIG. 40 is a flowchart illustrating a method of delivering a fluid to apatient using a fluid transfer device according to an embodiment.

DETAILED DESCRIPTION

Devices and methods for delivering a fluid to a patient with reducedcontamination from dermally residing microbes or other contaminantsexterior to the body are described herein. In some embodiments, anapparatus includes a cannula assembly, a housing, a fluid reservoir, aflow control mechanism, and an actuator. The housing has a proximal endportion and a distal end portion and defines an inner volumetherebetween. The housing includes an inlet port configured to beremovably coupled to the cannula assembly. The fluid reservoir isfluidically coupled to the housing and configured to receive and isolatea first volume of bodily fluid withdrawn from a patient. The flowcontrol mechanism is at least partially disposed in the inner volume andis configured to move relative to the housing between a firstconfiguration and a second configuration. The flow control mechanismdefines a fluid flow path between the cannula assembly and the fluidreservoir in the first configuration. The actuator is operably coupledto the flow control mechanism to move the flow control mechanism fromthe first configuration, in which the inlet port is placed in fluidcommunication the fluid reservoir such that bodily fluid can flow fromthe cannula assembly, through the inlet port via the fluid flow path andto the fluid reservoir, to the second configuration, in which the fluidreservoir is fluidically isolated from the cannula assembly.

In some embodiments, a device for delivering a fluid to a patient withreduced contamination includes a housing, a fluid reservoir, and a flowcontrol mechanism. The housing has a proximal end portion and a distalend portion and defines an inner volume therebetween. The housingincludes a first port configured to be removably coupled to a cannulaassembly, and a second port configured to be fluidically coupled to afluid source. The fluid reservoir is fluidically coupleable to thecannula assembly and configured to receive and isolate a predeterminedvolume of bodily fluid withdrawn from the patient. The flow controlmechanism is at least partially disposed in the inner volume of thehousing and is configured to move between a first configuration and asecond configuration. When in the first configuration, the first port isplaced in fluid communication with the fluid reservoir such that bodilyfluid can flow from the cannula assembly, through the first port and tothe fluid reservoir. When in the second configuration, the fluidreservoir is fluidically isolated from the cannula assembly and fluidcan flow from the fluid source, in the second port, through the flowcontrol mechanism, out the first port and to the cannula assembly.

In some embodiments, a method of delivering a fluid to a patient using afluid transfer device includes establishing fluid communication betweenthe patient and the fluid transfer device. Once in fluid communication,a predetermined volume of a bodily fluid is withdrawn from the patient.The predetermined volume of bodily fluid is transferred to a fluidreservoir. The fluid transfer device is fluidically isolated from thefluid reservoir to sequester the predetermined volume of bodily fluid inthe fluid reservoir. The method further includes establishing fluidcommunication between the patient and a fluid source with the fluidtransfer device.

In some embodiments, an apparatus includes a housing, a cannulaassembly, a flow control mechanism, and a fluid reservoir. The flowcontrol mechanism is configured to move relative to the housing betweena first configuration and a second configuration. The cannula assemblyis coupled to the housing and fluidically coupled to the fluid reservoirwhen the flow control mechanism is in the first configuration. The fluidreservoir is fluidically isolated from the cannula assembly when theflow control mechanism is in a second configuration such that thecannula assembly can be fluidically coupled to an external fluidreservoir and/or an external fluid source.

As referred to herein, “bodily fluid” can include any fluid obtainedfrom a body of a patient, including, but not limited to, blood,cerebrospinal fluid, urine, bile, lymph, saliva, synovial fluid, serousfluid, pleural fluid, amniotic fluid, and the like, or any combinationthereof.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to setof walls, the set of walls can be considered as one wall with distinctportions, or the set of walls can be considered as multiple walls.Similarly stated, a monolithically constructed item can include a set ofwalls. Such a set of walls can include, for example, multiple portionsthat are in discontinuous from each other. A set of walls can also befabricated from multiple items that are produced separately and arelater joined together (e.g., via a weld, an adhesive or any suitablemethod).

As used in this specification, the words “proximal” and “distal” referto the direction closer to and away from, respectively, a user who wouldplace the device into contact with a patient. Thus, for example, the endof a device first touching the body of the patient would be the distalend, while the opposite end of the device (e.g., the end of the devicebeing manipulated by the user) would be the proximal end of the device.

FIGS. 1 and 2 are schematic illustrations of a fluid transfer device 100according to an embodiment, in a first and second configuration,respectively. Generally, the fluid transfer device 100 (also referred toherein as “transfer device”) is configured to facilitate the insertionof a piercing member (e.g., a needle, a trocar, a cannula, or the like)into a patient to withdrawal and isolate a predetermined amount ofbodily fluid from the patient containing, for example, dermally residingmicrobes. The fluid transfer device 100 is further configured tofacilitate the delivery of parenteral fluid to the patient that does notsubstantially contain, for example, the dermally residing microbes. Inother words, the transfer device 100 is configured to transfer andfluidically isolate the predetermined amount of bodily fluid, includingdermally residing microbes dislodged from a venipuncture, within acollection reservoir and deliver parenteral fluids to the patient thatare substantially free from the dislodged dermally residing microbesand/or other undesirable external contaminants.

The transfer device 100 includes a housing 101, a cannula assembly 120,a fluid reservoir 130, a flow control mechanism 140, and an actuator180. The housing 101 can be any suitable shape, size, or configurationand is described in further detail herein with respect to specificembodiments. As shown in FIG. 1, the housing 101 defines an inner volume111 that can movably receive and/or movably house at least a portion ofthe flow control mechanism 140, as described in further detail herein. Aportion of the housing 101 can be, at least temporarily, physically andfluidically coupled to the cannula assembly 120. For example, in someembodiments, a distal end portion of the housing 101 can include aninlet port 105 or the like configured to physically and fluidicallycouple to a lock mechanism (not shown in FIGS. 1 and 2) included in thecannula assembly 120. In such embodiments, the lock mechanism can be,for example, a Luer-Lok® or the like that can engage the port. In someembodiments, the housing 101 can be monolithically formed with at leasta portion of the cannula assembly 120. In other words, in someembodiments, the inlet port 105 can be monolithically formed with aportion of the cannula assembly 120 to define a fluid flow path betweena portion of the housing 101 the cannula assembly 120. In this manner, aportion of the housing 101 can receive a bodily fluid from and/ordeliver a parenteral fluid to a patient via a cannula included in thecannula assembly 120, as described in further detail herein.

The cannula assembly 120 can be any suitable configuration. For example,in some embodiments, the cannula assembly 120 includes an engagementportion and a cannula portion (not shown in FIGS. 1 and 2). In suchembodiments, the engagement portion can physically and fluidicallycouple the cannula assembly 120 to the housing 101 (e.g., it can be thelock mechanism physically and fluidically coupled to the inlet port 105as described above). The cannula portion can be configured to beinserted into a portion of a patient to deliver a fluid to or receive afluid from the patient. For example, in some embodiments, the cannulaportion can include a distal end with a sharp point configured to piercea portion of the patient to dispose the cannula portion, at least inpart, within a vein of the patient. In other embodiments, a piercingmember (e.g., a lumen defining needle) can be movably disposed withinthe cannula assembly 120 to facilitate the insertion of the cannulaportion 120 into the portion of the patient.

As shown in FIG. 1, the housing 101 can house and/or define the fluidreservoir 130. Similarly stated, in some embodiments, the fluidreservoir 130 can be disposed within and/or at least partially definedby the inner volume 111 of the housing 101. The fluid reservoir 130 canbe configured to receive a predetermined amount of the bodily fluid andfluidically isolate the bodily fluid from a volume outside the fluidreservoir 130, as described in further detail herein. While shown inFIGS. 1 and 2 as being disposed within the inner volume 111 of thehousing 101, in some embodiments, the fluid reservoir 130 can bedisposed substantially outside the housing 101. In such embodiments, thefluid reservoir 130 can be physically and fluidically coupled to aportion of the housing 101. For example, in some embodiments, the fluidreservoir 130 can be coupled to an outlet port (not shown in FIGS. 1 and2). In other embodiments, the fluid reservoir 130 can be operablycoupled to the housing 101 via an intervening structure, such as, forexample, a Luer-Lok® and/or flexible sterile tubing. In still otherembodiments, the fluid reservoir 130 can be monolithically formed withat least a portion of the housing 101.

The flow control mechanism 140 included in the transfer device 100 isdisposed, at least partially, within the inner volume 111 of the housing101 and can be moved between a first configuration (FIG. 1) and a secondconfiguration (FIG. 2). The flow control mechanism 140 can be anysuitable mechanism configured to control or direct a flow of a fluid.For example, in some embodiments, the flow control mechanism 140 caninclude a valve (e.g., a check valve or the like) that allows a flow ofa fluid in a single direction. In other embodiments, a valve canselectively control a flow of a fluid in multiple directions. In stillother embodiments, the flow control mechanism 140 can define one or morelumens configured to selectively receive a flow of a fluid. In suchembodiments, the flow control mechanism 140 can be moved relative to thehousing 101 to selectively place a lumen in fluid communication with aportion of the transfer device 100 (e.g., the housing 101, the cannulaassembly 120, and/or the fluid reservoir 130). For example, in someembodiments, a portion of the flow control mechanism 140 can be movablydisposed, at least temporarily, within the cannula assembly 120 toselectively place the fluid reservoir 130 in fluid communication withthe cannula assembly 120. In some embodiments, the portion of the flowcontrol mechanism 140 can include a piercing member such as, forexample, a needle configured to extend beyond a distal end of thecannula assembly 120 (not shown in FIGS. 1 and 2) to pierce the skin ofa patient and facilitate the insertion of the cannula assembly 120 intoa vein of the patient.

In some embodiments, the transfer device 100 can include an actuator 180operably coupled to the flow control mechanism 140 and configured tomove the flow control mechanism 140 between the first and the secondconfiguration. For example, in some embodiments, the actuator 180 can bea push button, a slider, a toggle, a pull-tab, a handle, a dial, alever, an electronic switch, or any other suitable actuator. In thismanner, the actuator 180 can be movable between a first positioncorresponding to the first configuration of the flow control mechanism140, and a second position, different from the first position,corresponding to the second configuration of the flow control mechanism140. In some embodiments, the actuator 180 can be configured foruni-directional movement. For example, the actuator 180 can be movedfrom its first position to its second position, but cannot be moved fromits second position back to its first position. In this manner, the flowcontrol mechanism 140 is prevented from being moved to its secondconfiguration before its first configuration, as described in furtherdetail herein.

In use, the flow control mechanism 140 can be in the first configurationto place the fluid reservoir 130 in fluid communication with the cannulaassembly 120, as indicated by the arrow AA in FIG. 1. In this manner,the fluid reservoir 130 can receive a flow of bodily fluid that caninclude dermally residing microbes dislodged during a venipuncture event(e.g., when the cannula assembly 120 and/or the flow control mechanism140 pierces the skin of the patient). In some embodiments, the fluidreservoir 130 can be configured to receive a predetermined volume of thebodily fluid. With a desired amount of bodily fluid transferred to thefluid reservoir 130, a user (e.g., a doctor, physician, nurse,technician, phlebotomist, etc.) can manipulate the actuator 180 to movethe flow control mechanism 140 from the first configuration to thesecond configuration. For example, the flow control mechanism 140 can bein the first configuration when the flow control mechanism 140 is in adistal position relative to the housing 101 (FIG. 1) and the actuator180 can move the flow control mechanism 140 in a proximal directionrelative to the housing 101 to place the flow control mechanism in thesecond configuration, as indicated by the arrow BB in FIG. 2. Moreover,when in the second configuration, the flow control mechanism 140 nolonger facilitates the fluidic coupling of the fluid reservoir 130 tothe cannula assembly 120. Thus, the fluid reservoir 130 is fluidicallyisolated from the cannula assembly 120.

While shown in FIGS. 1 and 2 as being moved in the proximal direction(e.g., in the direction of the arrow BB), in other embodiments, theactuator 180 can move the flow control mechanism 140 between the firstconfiguration and the second configuration in any suitable manner ordirection. For example, in some embodiments, the flow control mechanism140 can be moved in a rotational motion between the first configurationand the second configuration. In other embodiments, the flow controlmechanism 140 can be moved in a transverse motion (e.g., substantiallyperpendicular to the direction of the arrow BB). In such embodiments,the rotational or transverse motion can be such that the flow controlmechanism 140 selectively defines one or more fluid flow pathsconfigured to receive a fluid from a patient or to deliver a fluid tothe patient, as described in further detail herein.

In some embodiments, the movement of the flow control mechanism 140 tothe second configuration can substantially correspond to a physical andfluidic decoupling of at least a portion of the housing 101 from thecannula assembly 120 such that an external fluid reservoir 199 (e.g.,also referred to herein as “fluid source”) can be physically andfluidically coupled to the cannula assembly 120. For example, as shownin FIG. 2, in some embodiments, the housing 101 can be moved in theproximal direction (e.g., in the direction of the arrow BB) to bephysically and fluidically decoupled from the cannula assembly 120. Insome embodiments, the proximal movement of the flow control mechanism140 urges the housing 101 to move in the proximal direction. In otherembodiments, a user (e.g., a physician, phlebotomist, or nurse) can movethe housing 101 in the proximal direction. In this manner, the externalfluid reservoir 199 can be fluidically coupled to the cannula assembly120. Expanding further, with the predetermined amount of bodily fluidtransferred to the fluid reservoir 130, the external fluid reservoir 199can be fluidically coupled to the cannula assembly 120 to deliver a flowof a parenteral fluid that is substantially free from dermally residingmicrobes dislodged during the venipuncture event, as indicated by thearrow CC in FIG. 2. Similarly stated, the dermally residing microbesthat are dislodged during the venipuncture event can be entrained in theflow of the bodily fluid delivered to the fluid reservoir 130. Thus,when the flow control mechanism 140 is moved to the second configurationand the fluid reservoir 130 is fluidically isolated from the cannulaassembly 120, the external fluid reservoir 199 can deliver the flow ofparenteral fluid substantially free from dermally residing microbes.

While the housing 101 is shown in FIG. 2 as being moved in the proximaldirection such that the external fluid reservoir 199 can be physicallyand fluidically coupled to the cannula assembly 120, in otherembodiments, a housing need not be decoupled from a cannula assembly.For example, FIG. 3 is a schematic illustration of a transfer device 200according to an embodiment. The transfer device 200 includes a housing201, a cannula assembly 220, a fluid reservoir 230, and a flow controlmechanism 240.

As shown in FIG. 3, the housing 201 includes a proximal end portion 202and a distal end portion 203 and defines an inner volume 211therebetween. The distal end portion 203 can be physically andfluidically coupled to the cannula assembly 220, as described above inreference to FIG. 1. For example, in some embodiments, the distal endportion 203 can include an inlet port 205 (also referred to herein as“first port”) or the like that can be physically and fluidically coupledto the cannula assembly 220. The proximal end portion 202 includes anoutlet port 206 (also referred to herein as “second port”) that can bephysically and fluidically coupled to an external fluid reservoir 299.The external fluid reservoir 299 can be any suitable fluid reservoir andcan be coupled to the second port 206 via an adhesive, a resistance fit,a mechanical fastener, any number of mating recesses, a threadedcoupling, and/or any other suitable coupling or combination thereof. Forexample, in some embodiments, the external fluid reservoir 299 can besubstantially similar to known fluid reservoirs configured to deliver aparenteral fluid (e.g., a fluid source). In some embodiments, theexternal fluid reservoir 299 is monolithically formed with the secondport 206. In still other embodiments, the external fluid reservoir 299can be operably coupled to the second port 206 via an interveningstructure (not shown in FIG. 3), such as, for example, a flexiblesterile tubing. More particularly, the intervening structure can definea lumen configured to place the external fluid reservoir 299 in fluidcommunication with the second port 206.

The housing 201 can house or define at least a portion of the fluidreservoir 230. Similarly stated, the fluid reservoir 230 can be at leastpartially disposed within the inner volume 211 of the housing 201. Thefluid reservoir 230 can receive and fluidically isolate a predeterminedamount of the bodily fluid, as described above in reference to FIGS. 1and 2. Similarly, the flow control mechanism 240 is at least partiallydisposed within the inner volume 211 of the housing 201 and can be movedbetween a first configuration and a second configuration. Morespecifically, the flow control mechanism 240 defines a first lumen 246that fluidically couples the cannula assembly 220 to the fluid reservoir230 when the flow control mechanism 240 is in the first configurationand a second lumen 247 that fluidically couples the cannula assembly 220to the external fluid reservoir 299 when the flow control mechanism 240is in the second configuration.

In use, the flow control mechanism 240 can be placed in the firstconfiguration to fluidically couple the cannula assembly 220 to thefluid reservoir 230 via the first lumen 246. In this manner, a flow of abodily fluid can be delivered to the fluid reservoir 230, as indicatedby the arrow DD in FIG. 3. More specifically, the bodily fluid can flowfrom the cannula assembly 220, through the first port 205 (e.g., theinlet port) and into the fluid reservoir 230. As described above in theprevious embodiment, the flow of the bodily fluid can contain dermallyresiding microbes dislodged by a venipuncture event (e.g., the insertionof a portion of the cannula assembly 220 into a vein of the patient).

With a predetermined amount of bodily fluid disposed within the fluidreservoir 230, the flow control mechanism 240 can be moved (e.g., by anactuator and/or manual intervention from the user) to the secondconfiguration to fluidically isolate the fluid reservoir 230 from thecannula assembly 220. More specifically, the flow control mechanism 240can be moved from the first configuration to fluidically isolate thefirst lumen 246 from the cannula assembly 220 and/or the fluid reservoir230, thereby fluidically isolating the fluid reservoir 230 from thecannula assembly 220. In addition, the movement of the flow controlmechanism 240 to the second configuration can place the second lumen 247in fluid communication with the cannula assembly 220 and the outlet port206 (e.g., the second port) disposed at the proximal end portion 202 ofthe housing 201. Thus, the external fluid reservoir 299 can befluidically coupled (as described above) to the second port 206 todeliver a flow of parenteral fluid to the patient via the second lumen247 and the cannula assembly 220, as indicated by the arrow EE. Forexample, the flow of parenteral fluid can flow from the external fluidreservoir 299 (e.g., a fluid source), in the second port 206, throughthe second lumen 247 defined by the flow control mechanism 240, out thefirst port 205 and to the cannula assembly 220 to be delivered to thepatient. Moreover, the flow of the parenteral fluid is substantiallyfree from dermally residing microbes and/or other undesirable externalcontaminants.

In some embodiments, the transfer device 200 can be configured such thatthe first amount of bodily fluid needs to be conveyed to the fluidreservoir 230 before the transfer device 200 will permit the flow of theparenteral fluid to be conveyed through the transfer device 200 to thepatient. In this manner, the transfer device 200 can be characterized asrequiring compliance by a health care practitioner regarding thecollection of the predetermined amount of bodily fluid prior to thedelivery of the parenteral fluid. Similarly stated, the transfer device200 can be configured to prevent a health care practitioner fromdelivering the parenteral fluid to the patient without first divertingor transferring the predetermined amount of bodily fluid to the fluidreservoir 230. In this manner, the health care practitioner issubstantially prevented from introducing (whether intentionally orunintentionally) bodily surface microbes and/or other undesirableexternal contaminants into, for example, the flow of the parenteralfluid and/or the blood stream of the patient. In other embodiments, thefluid transfer device 200 need not include a forced-compliance featureor component.

FIGS. 4-10 illustrate a transfer device 300 according to an embodiment.The transfer device 300 includes a housing 301, a cannula assembly 320,a fluid reservoir 330, a flow control mechanism 340, and an actuator380. The transfer device 300 can be any suitable shape, size, orconfiguration. For example, while shown in FIG. 4 as being substantiallycylindrical, the transfer device 300 can be square, rectangular,polygonal, and/or any other non-cylindrical shape. Moreover, any portionof the transfer device 300 can include any feature or finish configuredto enhance the ergonomics of the transfer device 300. For example, thehousing 301 can include a portion configured to form a grip configuredto be engaged by a user's hand.

The housing 301 includes a proximal end portion 302 and a distal endportion 303 and defines an inner volume 311 therebetween (see e.g., FIG.6). As shown in FIG. 5, the proximal end portion 302 of the housing 301includes a protrusion 304 that selectively engages a portion of thefluid reservoir 330, as described in further detail herein. The distalend portion 303 of the housing 301 is coupled to a port 305. Morespecifically, the port 305 can be coupled to the distal end portion 303in any suitable manner such as, for example, via a friction fit, athreaded coupling, a mechanical fastener, an adhesive, any number ofmating recesses, and/or any combination thereof. In other embodiments,the port 305 can be monolithically formed with the housing 301.Moreover, the port 305 can be coupled to the distal end portion 303 ofthe housing 301 such that a seal member 316 is disposed between the port305 and a distal wall 308 of the housing 301. In this manner, when theport 305 is coupled to the housing 301, the seal member 316 can engagethe distal wall 308 of the housing 301 and the port 305 to selectivelyform a substantially fluid tight seal, as described in further detailherein.

As shown in FIG. 6, the port 305 is removably coupled to a lockmechanism 321 of the cannula assembly 320. The lock mechanism 321 of thecannula assembly 320 can be, at least temporarily, coupled to the port305 to selectively place the housing 301 in fluid communication with thecannula assembly 320. For example, in some embodiments, the lockmechanism 321 can be a Luer-Lok® that receives a portion of the port 305to physically and fluidically couple the cannula assembly 320 to thehousing 301. In other embodiments, the lock mechanism 321 and the port305 can be removably coupled in any suitable manner.

As shown in FIGS. 5 and 6, the fluid reservoir 330 defines an innervolume 333 between a proximal end portion 331 and a distal end portion332. More specifically, the inner volume 333 is closed at the proximalend portion 331 of the fluid reservoir 330 such that at the proximalend, the inner volume 333 is fluidically isolated from a volume outsidethe fluid reservoir 330. Conversely, the distal end portion 332 of thefluid reservoir 330 is open such that at the distal end, the innervolume 333 can be in fluid communication with a volume outside the fluidreservoir 330. The distal end portion 332 of the fluid reservoir 330 ismovably disposed about the proximal end portion 302 of the housing 301,as shown in FIG. 6. Similarly stated, the proximal end portion 302 ofthe housing 301 is movably disposed within the inner volume 333 definedby the fluid reservoir 330 such that the inner volume 311 defined by thehousing 301 is in fluid communication with the inner volume 333 of thefluid reservoir 330. Moreover, the distal end portion 332 of the fluidreservoir 330 includes a protrusion 335 that can be placed in contactwith the protrusion 304 disposed at the proximal end portion 302 of thehousing 301 to substantially limit the movement of the fluid reservoir330 relative to the housing 301, as described in further detail herein.

The flow control mechanism 340 included in the transfer device 300 is atleast partially disposed within the inner volume 311 of the housing 301and is configured to be moved between a first configuration and a secondconfiguration. Expanding further, the flow control mechanism 340 is inthe first configuration when disposed in a distal position relative tothe housing 301 (see e.g., FIG. 6) and is in the second configurationwhen disposed in a proximal position relative to the housing 301 (seee.g., FIG. 9). As shown in FIGS. 6 and 7, the flow control mechanism 340includes a first member 341 and a second member 360. The first member341 includes a proximal end portion 342 and a distal end portion 343 anddefines a lumen 346 therethrough. The first member 341 can be anysuitable shape, size, or configuration. For example, as shown in FIG. 5,the first member 341 can be substantially cylindrical and can have adiameter substantially corresponding to the diameter of the inner volume311 of the housing 301.

The second member 360 of the flow control mechanism 340 includes aproximal end portion 361 and a distal end portion 362 and defines alumen 363 therethrough. As shown in FIG. 6, at least a portion of thesecond member 360 is movably disposed within the cannula assembly 320.More specifically, the second member 360 can be substantiallycylindrical and can have a diameter substantially corresponding to theinner diameter of the cannula 324 included in the cannula assembly 320.As shown in the enlarged view of FIG. 7, the proximal end portion 361 ofthe second member 360 is configured to extend through the port 305 andthe seal member 316 (described above), and through an opening 309defined in the distal wall 308 to allow the second member 360 to becoupled to the first member 341. Expanding further, the proximal endportion 361 of the second member 360 is disposed within the lumen 346defined by the first member 341. In some embodiments, the proximal endportion 361 of the second member 360 can form a friction fit with thewalls of the first member 341 that define the lumen 346, therebycoupling the second member 360 to the first member 341. In otherembodiments, the second member 360 can be coupled to the first member341 via an adhesive or the like.

The distal end portion 362 of the second member 360 is configured toextend beyond a distal end of the cannula 324 included in the cannulaassembly 320, when the flow control mechanism 340 is in the firstconfiguration. Furthermore, the distal end portion 362 of the secondmember 360 can include a sharp point that can facilitate the insertionof the transfer device 300 (e.g., the flow control mechanism 340 and thecannula assembly 320) into a portion of a patient. For example, thedistal end portion 362 of the second member 360 can be used to access avein of the patient and facilitate the introduction of the cannula 324into the vein. Moreover, with the cannula 324 and the distal end portion362 of the second member 360 disposed within the vein of the patient thetransfer device 300 can be configured to transfer a portion of a bodilyfluid from the patient to the fluid reservoir 330 to prevent injectionof dislodged dermally residing microbes that have been incompletelysterilized by surface antisepsis and/or other undesirable externalcontaminants.

As shown in FIG. 8, the transfer device 300 can be moved to a secondconfiguration to begin a flow of bodily fluid (e.g., blood) from thepatient to the transfer device 300. More specifically, the fluidreservoir 330 can be moved in the proximal direction relative to thehousing 301 to place the transfer device 300 in the secondconfiguration, as indicated by the arrow FF. The arrangement of thefluid reservoir 330 and the housing 301 is such that the proximal motionof the fluid reservoir 330, relative to the housing 301, increases theinner volume 333 defined by the fluid reservoir 330. Expanding further,the proximal end portion 302 of the housing 301 can be disposed withinthe inner volume 333 of the fluid reservoir 330 such that the protrusion304 engages an inner surface of the fluid reservoir 330 to define asubstantially fluid tight seal. In addition, the protrusion 335 of thefluid reservoir 330 can be placed in contact with the protrusion 304 ofthe housing 301 to limit the proximal motion of the fluid reservoir 330relative to the housing 301. In this manner, the proximal motion of thefluid reservoir 330 relative to the housing 301 increases the collectivevolume of both the inner volume 311 defined by the housing 301 and theinner volume 333 of the fluid reservoir 330.

The increase of volume introduces a negative pressure within the innervolume 333 of the fluid reservoir 330 and within the inner volume 311 ofthe housing 301. Therefore, with the cannula 324 and the second member360 of the flow control mechanism 340 disposed within the vein of thepatient, the negative pressure urges a flow of bodily fluid (e.g.,blood) through the lumen 363 and 346 defined by the second member 360and first member 341 of the flow control mechanism 340, respectively. Asindicated by the arrow GG in FIG. 8, the bodily fluid can flow throughthe lumen 363 and 346 of the flow control mechanism 340 and enter thecollective volume formed and/or defined by the inner volume 311 of thehousing 301 and the inner volume 333 of the fluid reservoir 330.

As shown in FIG. 9, when a predetermined amount of bodily fluid isdisposed within the fluid reservoir 330, the flow control mechanism 340can be moved to its second configuration (e.g., the proximal positionrelative to the housing 301) to place the transfer device 300 a thirdconfiguration. More specifically, the flow control mechanism 340includes a spring 349 that is in contact with the distal wall 308 of thehousing 301 and the distal end portion 343 of the first member 341included in the flow control mechanism 340. As shown in FIGS. 6-8, thespring 349 is maintained in a compressed configuration while thetransfer device 300 is in the first and second configuration. As shownin FIG. 9, when the spring 349 is allowed to expand, the spring 349exerts a force to move the flow control mechanism 340 in the proximaldirection, as indicated by the arrow HH. In some embodiments, theexpansion of the spring 349 can be in response to the actuator 380. Theactuator 380 can be any suitable mechanism configured to selectivelyinteract with the spring 349 such as, for example, a push button. Inother embodiments, the actuator 380 can be a slider, a pull-tab, alever, a toggle, an electronic switch, or the like.

The proximal motion of the flow control mechanism 340 can be such thatboth the first member 341 and the second member 360 of the flow controlmechanism 340 are disposed within the collective volume defined by thefluid reservoir 330 and the housing 301. Similarly stated, the spring349 moves the flow control mechanism 340 in the proximal direction asufficient distance to move the distal end portion 362 of the secondmember 360 through the port 305, the seal member 316, and the distalwall 308 to be disposed within the housing 301. Furthermore, the sealmember 316 can be configured such that as the distal end portion 362passes beyond the distal wall 308 of the housing 301, the seal member316 acts to seal the opening 309 through which the second member 360 wasdisposed. Thus, when the flow control mechanism 340 is completelydisposed within the collective volume defined by the housing 301 and thefluid reservoir 330 (e.g., the combination of the inner volume 311 andthe inner volume 333, respectively), the seal member 316 seals thedistal end portion 303 of the housing 301 and the fluid reservoir 330 issubstantially fluidically isolated from the cannula assembly 320.

With the fluid reservoir 330 fluidically isolated from the cannulaassembly 320, the transfer device 300 can be placed in a fourthconfiguration, as shown in FIG. 10. More specifically, the housing 301and the fluid reservoir 330 can be collectively moved in the proximaldirection such that the port 305 is physically decoupled from the lockmechanism 321 of the cannula assembly 320, as indicated by the arrow II.In this manner, the fluid reservoir 330 can contain and fluidicallyisolate a portion of the bodily fluid (e.g., blood) that includes, forexample, dermally residing microbes dislodged during the venipunctureevent (e.g., the insertion of the distal end portion 362 of the secondmember 360 of the flow control mechanism 340). Furthermore, with theport 305 decoupled from the lock mechanism 321 of the cannula assembly320, the cannula assembly 320 can be physically and fluidically coupledto an external fluid reservoir (not shown in FIG. 10) that can deliver aflow of a parenteral fluid that is substantially free from the dermallyresiding microbes.

While the fluid reservoir 330 is shown in FIGS. 4-10 as being disposedabout a portion of the housing 301, in some embodiments, a transferdevice can include a fluid reservoir the is substantially enclosedwithin a housing. For example, FIGS. 11-15 illustrate a transfer device400 according to an embodiment. The transfer device 400 includes ahousing 401, a cannula assembly 420, a fluid reservoir 430, a flowcontrol mechanism 440, and an actuator 480. As shown in FIGS. 11 and 12,the overall size and shape of the transfer device 400 can besubstantially similar to the overall size and shape of the transferdevice 300 described above in reference to FIG. 4. In addition, thecannula assembly 420, the flow control mechanism 440, and the actuator480 can be substantially similar in form and function to the cannulaassembly 320, the flow control mechanism 340, and the actuator 380included in the transfer device 300, described above in reference toFIGS. 4-10. Therefore, the cannula assembly 420, the flow controlmechanism 440, and the actuator 480 are not described in further detailherein.

The housing 401 of the transfer device 400 includes a proximal endportion 402 and a distal end portion 403 and defines an inner volume 411therebetween. More specifically, the housing 401 is substantially closedat the proximal end portion 402 such that at the proximal end, the innervolume 411 is fluidically isolated from a volume outside the housing401. The distal end portion 403 of the housing 401 is coupled to a port405. The port 405 is substantially similar to the port 305 describedabove, and can be coupled to the distal end portion 403 of the housing401 such that a seal member 416 is disposed between the port 405 and adistal wall 408 of the housing 401. In this manner, the seal member 416can form a substantially fluid tight seal between the distal wall 408and the port 405 (described in detail with reference the port 305 shownin FIGS. 6 and 7). Furthermore, the port 405 can be configured toremovably couple the housing 401 to the cannula assembly 420. Forexample, the port 405 can be, at least temporarily, physically andfluidically coupled to a lock mechanism 421 included in the cannulaassembly 420. In this manner, the housing 401 and the cannula assembly420 can be selectively placed in fluid communication.

The fluid reservoir 430 included in the transfer device 400 is movablydisposed within the inner volume 411 defined housing 401. Morespecifically, the fluid reservoir 430 is configured to move within thehousing 401 between a first configuration (FIG. 13) and a secondconfiguration (FIG. 14). The fluid reservoir 430 defines an inner volume433 between a proximal end portion 431 and a distal end portion 432. Theinner volume 433 is configured to selectively receive at least a portionof the flow control mechanism 440. Furthermore, the flow controlmechanism 440 can moved between a first position and a second positionto move the fluid reservoir 430 between the first configuration and thesecond configuration, as described in further detail herein.

As shown in FIG. 13, the flow control mechanism 440 is in the firstposition when disposed in a distal position relative to the housing 401.While in the first position, a first member 441 of the flow controlmechanism 440 is completely contained within the inner volume 433 and asecond member 460 is configured to extend from the first member 441through the distal end portion 432 of the fluid reservoir 430. Thesecond member 460 of the flow control mechanism 460 further extendsthrough the housing 401 and the port 405 to be at least partiallydisposed within the cannula assembly 420 (as described above in detailwith reference to the second member 360 shown in FIGS. 6 and 7). In thismanner, a distal end portion 462 of the second member 460 can extendbeyond a cannula 424 of the cannula assembly 420 to facilitate theinsertion of the cannula 424 into a portion of a patient. Moreover, withthe distal end portion 462 of the second member 460 disposed within theportion of the patient, a lumen 463 defined by the second member 460 anda lumen 446 defined by the first member 441 can place the fluidreservoir 430 in fluid communication with the portion of the patient.

In use, the transfer device 400 can be moved from the firstconfiguration (FIG. 13) to the second configuration (FIG. 14) tofacilitate the flow of a bodily fluid (e.g., blood) into the fluidreservoir 430. More specifically, the flow control mechanism 440includes a mechanical actuator 449 (e.g., a spring) that is in contactwith the distal wall 408 of the housing 401 and the first member 441 ofthe flow control mechanism 440. As shown in FIG. 13, the mechanicalactuator 449 is maintained in a compressed configuration while thetransfer device 400 is in the first configuration. Similarly stated, theflow control mechanism 440 is in the first position relative to thehousing 401 when the mechanical actuator 449 is in the compressedconfiguration. As shown in FIG. 14, when the mechanical actuator 449 isallowed to expand, the mechanical actuator 449 exerts a force to movethe flow control mechanism 440 in the proximal direction, as indicatedby the arrow JJ. In some embodiments, the expansion of the mechanicalactuator 449 can be in response to an actuation of the actuator 480.

The proximal motion of the flow control mechanism 440 moves within theinner volume 433 to place the first member 441 in contact with theproximal end portion 441 of the fluid reservoir 430. In this manner, theflow control mechanism 440 urges the proximal end portion 431 of thefluid reservoir 430 to move in the direction of the arrow JJ (e.g., theproximal direction). Moreover, the distal end portion 432 of the fluidreservoir 430 can be coupled to the distal wall 408 of the housing 401such that as the proximal end portion 431 moves in the proximaldirection, the fluid reservoir 430 expands. Similarly stated, the fluidreservoir 430 can form a bellows in which the proximal motion of theflow control mechanism 440 moves the fluid reservoir 430 from acompressed configuration (e.g., the first configuration) to an expandedconfiguration (e.g., the second configuration).

The movement of the proximal end portion 431 relative to the distal endportion 432 increases the inner volume 433 defined by the fluidreservoir 430 and introduces a negative pressure within the inner volume433. Moreover, with the lumen 446 of the first member 441 and the lumen463 of the second member 460 in fluid communication with the fluidreservoir 430, at least a portion of the negative pressure istransferred through the flow control mechanism 440. Therefore, while theflow control mechanism 440 is being moved to the second position (FIG.14), the negative pressure urges a flow of bodily fluid (e.g., blood)through the lumen 463 and 446 defined by the second member 460 and firstmember 441 of the flow control mechanism 440, respectively. Expandingfurther, as shown in FIG. 14, the proximal motion of the flow controlmechanism 440 is such that the second member 460 is retracted to aproximal position relative to the distal wall 408 of the housing 401.Prior to being disposed in the proximal position relative to the distalwall 408, however, the lumen 463 is maintained in fluid communicationwith the portion of the patient via the cannula 424. In this manner, theflow control mechanism 440 transfers the bodily fluid to the fluidreservoir 430 while being moved in the proximal direction and prior tobeing disposed in the second position. Thus, when the second member 460is retracted to the proximal position relative to the distal wall 408,the flow control mechanism 440 has transferred a predetermined amount ofbodily fluid to the fluid reservoir 430 and the seal member 416 can actto fluidically isolate the fluid reservoir 430. Similarly stated, theflow control mechanism 440 is configured to transfer the predeterminedamount of bodily fluid to the fluid reservoir 430 concurrently with theproximal motion of both the flow control mechanism 440 and the fluidreservoir 430.

With the fluid reservoir 430 fluidically isolated from the cannulaassembly 420, the transfer device 400 can be placed in a thirdconfiguration, as shown in FIG. 15. More specifically, the housing 401and the fluid reservoir 430 can be collectively moved in the proximaldirection to physically decouple the port 405 from the lock mechanism421 of the cannula assembly 420, as indicated by the arrow KK. In someembodiments, the actuator 480 can facilitate the decoupling of the port405 from the lock mechanism 421. In other embodiments, a second actuator(not shown) can be engaged to decouple the port 405 from the lockmechanism 421. In other embodiments, an actuator need not be engaged todecouple the port 405 from the lock mechanism 421.

With the port 405 decoupled from the lock mechanism 421, the fluidreservoir 430 can contain and fluidically isolate a portion of thebodily fluid (e.g., blood) that includes, for example, dermally residingmicrobes dislodged during the venipuncture event (e.g., the insertion ofthe distal end portion 462 of the second member 460 of the flow controlmechanism 440). Furthermore, with the port 405 decoupled from the lockmechanism 421, the cannula assembly 420 can be physically andfluidically coupled to an external fluid reservoir (not shown in FIG.15) that can deliver a flow of a parenteral fluid that is substantiallyfree from the dermally residing microbes, as described above.

While the fluid reservoir 430 is shown in FIGS. 11-15 as being disposedwithin the inner volume 411 of the housing 401, in some embodiments, afluid reservoir can be physically and fluidically coupled to a portionof the transfer device. For example, FIGS. 16-23 illustrate a transferdevice 500 according to an embodiment. The transfer device 500 includesa housing 501, a cannula assembly 520, a flow control mechanism 540, andan actuator mechanism 580. As shown in FIGS. 16 and 17, the overall sizeand shape of the transfer device 500 can be substantially similar to theoverall size and shape of the transfer device 300 described above inreference to FIG. 4. In other embodiments, the overall size and shape ofthe transfer device 500 can be square, rectangular, polygonal, and/orany other non-cylindrical shape. In addition, the cannula assembly 520can be substantially similar in form and function to the cannulaassembly 320 included in the transfer device 300, described above inreference to FIGS. 4-10. Therefore, the cannula assembly 520 is notdescribed in further detail herein.

As shown in FIG. 18, the housing 501 of the transfer device 500 includesa proximal end portion 502 and a distal end portion 503 and defines aninner volume 511 therebetween. The housing 501 is substantially closedat the proximal end portion 502 such that at the proximal end, the innervolume 511 is fluidically isolated from a volume outside the housing501. The distal end portion 503 of the housing 501 includes a distalwall 508 that defines an opening 509 configured to receive, at leasttemporarily, a portion of the flow control mechanism 540, as describedin further detail herein. The housing 501 further defines an actuatorchamber 510 configured to receive at least a portion of the actuatormechanism 580. As shown in FIG. 18, the walls of the housing 501 can bearranged such that the actuator chamber 510 is a bore with a centerlinethat is substantially perpendicular to a centerline defined by the innervolume 511.

Referring back to FIG. 17, the actuator mechanism 580 includes a firstactuator member 581 and a second actuator member 585. As described infurther detail herein, the actuator mechanism 580 can be moved between afirst configuration (see e.g., FIG. 16) and a second configuration (seee.g., FIG. 21). The first actuator member 581 can be rotatably coupledto the walls of the housing 501 defining the actuator chamber 510.Similarly stated, the first actuator member 581 is configured to bedisposed substantially outside the housing 501 and can be rotatablycoupled to the walls of the housing 501 that define the actuator chamber510. The first actuator member 581 includes an engagement portion 582and a port 583 configured to be physically and fluidically coupled to afluid reservoir, as described in further detail herein.

As shown in FIG. 19, the second actuator member 585 can be substantiallycylindrical and is configured to be disposed within the actuator chamber510 defined by the housing 501. The second actuator member 585 defines alumen 587 and a flow control channel 588. The lumen 587 is configured tobe in fluid communication with the port 583 of the first actuator member581. In this manner, the lumen 587 and the port 583 can receive a flowof a bodily fluid when the actuator mechanism 580 is in the firstconfiguration, as described in further detail herein. The flow controlchannel 588 is configured to receive at least a portion of the flowcontrol mechanism 540 when the actuator mechanism 580 is placed in thesecond configuration, as described in further detail herein.

The flow control mechanism 540 included in the transfer device 500 is atleast partially disposed within the inner volume 511 of the housing 501and is configured to be moved between a first position and a secondposition. Expanding further, the flow control mechanism 540 is in thefirst position when disposed in a distal position relative to thehousing 501 (see e.g., FIG. 20) and is in the second position whendisposed in a proximal position relative to the housing 501 (see e.g.,FIG. 22). As shown in FIGS. 17 and 20, the flow control mechanism 540includes a first member 541 and a second member 560. The first member541 includes a proximal end portion 542 and a distal end portion 543 anddefines a lumen 546 therethrough. The first member 541 can be anysuitable shape, size, or configuration. For example, as shown in FIG.17, the first member 541 can be substantially cylindrical with theproximal end portion 542 having a first diameter that substantiallycorresponds to the diameter of the flow control channel 588 defined bythe second actuator member 585. As shown in FIG. 20, the first member541 can be configured such that when the flow control mechanism 540 isin the first position, the lumen 546 defined by the first member 541 isin fluid communication with the lumen 587 defined by the second actuatormember 585, as described in further detail herein.

The distal end portion 543 of the first member 541 can have a seconddiameter, smaller than the first diameter, substantially correspondingto an inner diameter of a lock mechanism 521 included in the cannulaassembly 520. For example, in some embodiments, the distal end portion543 can extend through the opening 509 defined by the distal wall 508 ofthe housing 501 to be disposed within the lock mechanism 521. In someembodiments, the distal end portion 543 can form a friction fit with aninner surface of the lock mechanism 521 to removably couple the flowcontrol mechanism 540 to the cannula assembly 520. Furthermore, with theproximal end portion 542 of the first member 541 disposed in a proximalposition relative to the distal wall 508 and with the diameter of theproximal end portion 542 substantially larger than the diameter of theopening 509, the flow control mechanism 540 operatively couples thehousing 501 to the cannula assembly 520.

The second member 560 of the flow control mechanism 540 includes aproximal end portion 561 and a distal end portion 562 and defines alumen 563 therethrough. As shown in FIG. 20, at least a portion of thesecond member 560 is movably disposed within a cannula 524 of thecannula assembly 520. As described above with respect to the flowcontrol mechanism 340, the proximal end portion 561 of the second member560 is configured to extend through the lock mechanism 521 to be coupledto the first member 541. Expanding further, the proximal end portion 561of the second member 560 is disposed within the lumen 546 defined by thefirst member 541. The distal end portion 562 of the second member 560 isconfigured to extend beyond a distal end of the cannula 524 included inthe cannula assembly 520, when the flow control mechanism 540 is in thefirst configuration. In this manner, the second member 560 canfacilitate the insertion of the transfer device 500 into a portion of apatient (e.g., the distal end can include a sharp point) and can furtherfacilitate a transfer of a bodily fluid from the patient to a fluidreservoir (e.g., via the lumen 563).

For example, as shown in FIG. 20, the transfer device 500 can be in afirst configuration when the flow control mechanism 540 is in the firstposition and the actuator mechanism 580 is in its first configuration.In this manner, the second member 560 of the flow control mechanism 540and the cannula 524 of the cannula assembly 520 can be inserted into aportion of the patient, such as a vein, to place the transfer device 500in fluid communication with the portion of the patient. Furthermore, afluid reservoir (not shown in FIGS. 16-23) can be physically andfluidically coupled to the port 583 of the second actuator member 581.The arrangement of the flow control mechanism 540 and the actuatormechanism 580 is such that when the fluid reservoir is physically andfluidically coupled to the port 583, the fluid reservoir is in fluidcommunication with the lumen 587 defined by the second actuator member585 and the two lumen 546 and 563 defined by the first member 541 andthe second member 560 of the flow control mechanism 540, respectively.In some embodiments, the fluid reservoir can be, for example, aVacutainer®. In such embodiments, the fluid reservoir can define anegative pressure such that when fluidically coupled to the port 583,the fluid reservoir introduces a suction force within the portion of thepatient (e.g., via the lumen 587, 546, and 563). In this manner, aportion of the suction force can urge a flow of bodily fluid through thelumen 563, 546, and 587 and into the fluid reservoir, as indicated bythe arrow LL in FIG. 20. Moreover, the flow of bodily fluid can be suchthat dermally residing microbes dislodged during a venipuncture event(e.g., the insertion of the flow control mechanism 540 and the cannula524) become entrained therein and are transferred to the fluidreservoir.

With a predetermined amount of bodily fluid transferred to the fluidreservoir, the fluid reservoir can be decoupled from the port 583 (e.g.,physically and fluidically or only fluidically). In this manner, a usercan engage the first actuator member 581 to move the actuator mechanism580 to its second configuration and thereby place the transfer device ina second configuration. For example, as indicated by the arrow MM inFIG. 21, the user (e.g., a physician, a nurse, a phlebotomist, etc.) canrotate the first actuator member 581 in a clockwise direction relativeto the housing 501.

The actuator mechanism 580 is such that the rotation of the firstactuator member 581 urges the second actuator member 585 to also rotaterelative to the housing 501. In this manner, a centerline defined by theflow control channel 587 is rotated from a first configuration in whichthe centerline is substantially perpendicular to the centerline definedby the inner volume 511 to a second configuration in which thecenterline is substantially parallel to the centerline of the innervolume 511. Similarly stated, the second actuator member 585 is rotatedsuch that the centerline defined by the flow control channel 587 isaligned with the centerline defined by the inner volume 511.

As shown in FIG. 22, the rotation of the actuator mechanism 580 towardthe second configuration can facilitate the movement of the flow controlmechanism 540 from the first position toward the second position. Morespecifically, the flow control mechanism 540 includes a spring 549 thatis disposed about the distal end portion 543 of the first member 541 andis in contact with the distal wall 508 of the housing 501 and a surfaceof the first member 541. The spring 549 is maintained in a compressedconfiguration while the transfer device 500 is in the firstconfiguration. For example, as shown in FIG. 20, a proximal surface ofthe first member 541 of the flow control mechanism 540 can be in contactwith a surface of the second actuator mechanism 585 such that the secondactuator mechanism 585 prevents proximal movement of the flow controlmechanism 540. When the actuator mechanism 580 is moved to the secondconfiguration and the flow control channel 587 is aligned with the innervolume 511 (as described above), however, the proximal surface of thefirst member 541 is no longer in contact with the surface of the secondactuator member 585 and the spring 549 is allowed to expand.

The expansion of the spring 549 exerts a force on the first member 541of the flow control mechanism 540 to move the flow control mechanism 540in the proximal direction, as indicated by the arrow NN in FIG. 22. Inthis manner, the flow control mechanism 540 can pass through the flowcontrol channel 587 defined by the second actuator member 585 to bedisposed in the second position (e.g., the distal position). Theproximal motion of the flow control mechanism 540 is such that both thefirst member 541 and the second member 560 of the flow control mechanism540 are disposed within the inner volume 511 defined by the housing 501.Similarly stated, the spring 549 moves the flow control mechanism 540 inthe proximal direction a sufficient distance to move the distal endportion 562 of the second member 560 through the opening 509 defined bythe distal wall 508 to be disposed within the housing 501.

As shown in FIG. 23, with the flow control mechanism 540 disposed withinthe housing 501, the distal end portion 543 of the first member 541 isno longer disposed within the lock mechanism 521 of the cannula assembly520. In this manner, the housing 501 is physically and fluidicallydecoupled from the cannula assembly 520 and can be moved away from thecannula assembly 520, as indicated by the arrow OO in FIG. 23.Furthermore, with the housing 501 decoupled from the lock mechanism 521,the cannula assembly 520 can be physically and fluidically coupled to anexternal fluid reservoir (not shown in FIG. 23) that can deliver a flowof a parenteral fluid to the portion of the patient that issubstantially free from the dermally residing microbes.

While the transfer devices described above are configured to include acannula assembly that is physically and fluidically decoupled from aportion of the transfer device to receive a parenteral fluid, in someembodiments, a transfer device can include a cannula assembly configuredto remain physically coupled to a portion of the transfer device. Forexample, FIGS. 24-30 illustrate a transfer device 600 according to anembodiment. The transfer device 600 includes a housing 601, a cannulaassembly 620, a fluid reservoir 630, and a flow control mechanism 640.In use, the transfer device 600 can be moved between a first, a second,and a third configuration to receive a predetermined amount of a bodilyfluid from a patient and to deliver a flow of a parenteral fluid to thepatient that is substantially free from, for example, dermally residingmicrobes.

As shown in FIGS. 24 and 25, the housing 601 includes a proximal endportion 602 and a distal end portion 603 and defines an inner volume 611therebetween. The proximal end portion 602 is substantially open suchthat the inner volume 611 can selectively receive the fluid reservoir630 and at least a portion of the flow control mechanism 640. Inaddition, the proximal end portion 602 includes a protrusion 604configured to engage a portion of the flow control mechanism 640, asdescribed in further detail herein.

The distal end portion 603 of the housing 601 includes a distal port 605and a reservoir seat 618. The reservoir seat 618 is configured toengage, at least temporarily, a portion of the fluid reservoir 630, asdescribed in further detail herein. The distal port 605 is configured tobe physically and fluidically coupled to a lock mechanism 621 includedin the cannula assembly 620. For example, in some embodiments, the lockmechanism 621 can be a Luer-Lok® configured to receive the port 605. Inother embodiments, the port 605 and the lock mechanism 621 can becoupled in any suitable manner such as, for example, a threadedcoupling, a friction fit, or the like. In still other embodiments, theport 605 and the lock mechanism 621 can be coupled via an adhesive orthe like to fixedly couple the cannula assembly 620 to the housing 601.With the lock mechanism 621 coupled to the port 605, the inner volume611 of the housing 601 is in fluid communication with a cannula 624included in the cannula assembly 620, as further described herein.

As described above, the fluid reservoir 630 is disposed within the innervolume 611 of the housing 601. More particularly, the fluid reservoir630 is movably disposed within the inner volume 611 between a firstposition in which the fluid reservoir 630 is in a distal positionrelative to the housing 601 (see e.g., FIG. 28) and a second position inwhich the fluid reservoir 630 is in a proximal position relative to thehousing 601 (see e.g., FIG. 30). As shown in FIG. 26, the fluidreservoir 630 includes a proximal end portion 631 and a distal endportion 632 and defines an inner volume 633 therebetween. The proximalend portion 631 includes a flange 634 and a protrusion 635 and defines aset of openings 636. Furthermore, the proximal end portion 631 of thefluid reservoir 630 is substantially open to receive a portion of theflow control mechanism 640. In this manner, the proximal end portion 631is configured to engage, interact, or otherwise correspond with aportion of the flow control mechanism 640, as further described herein.

The distal end portion 632 of the fluid reservoir 630 includes a valveseat 637. The valve seat 637 includes a port 638 and receives a valve639 (see e.g., FIG. 28-30). The valve seat 637 is selectively disposedabout the reservoir seat 618 of the housing 601, as described in furtherdetail herein. The valve 639 can be any suitable valve such as, forexample, a check valve or the like. In this manner, the distal endportion 632 can be selectively placed in fluid communication with theinner volume 611 when the fluid reservoir 630 is disposed within thehousing 601, as described in further detail herein.

As described above, the flow control mechanism 640 can be at leastpartially disposed within the housing 601. More particularly and asshown in FIG. 27, the flow control mechanism 640 includes an engagementportion 645 configured to be disposed outside the housing 601 and aplunger portion 650 configured to be at least partially disposed withinthe inner volume 611 defined by the housing 601. As described in furtherdetail herein, the engagement portion 645 can be engaged by a user tomove the flow control mechanism 640 between a first configuration and asecond configuration.

The plunger portion 650 of the flow control mechanism 640 is configuredto extend in a distal direction from a surface of the engagement portion645. The plunger 650 includes a first surface 652, a second surface 655,a protrusion 653, a first seal member 658, and a second seal member 659.As shown in FIG. 27, the plunger portion 650 is substantiallycylindrical and defines a channel 651 that receives, for example, acannula 664 that defines a lumen 646. More particularly, the cannula 664is configured to be disposed within an opening 654 defined by the firstsurface 652 to place the lumen 646 in fluid communication with an innervolume 656 defined between the first surface 652 and the second surface655. The plunger 650 is further configured to define a set of openings657 that can selectively place the inner volume 656 in fluidcommunication with a portion of the housing 601, as described in furtherdetail herein.

In use, the transfer device 600 can be moved between a firstconfiguration (FIG. 28), a second configuration (FIG. 29), and a thirdconfiguration (FIG. 30). Referring to FIG. 28, while in the firstconfiguration, the cannula 624 of the cannula assembly 620 can beinserted into a portion of a patient to place the cannula 624 in fluidcommunication with, for example, a vein. In some embodiments, thecannula 624 can include a sharp point at a distal end such that thecannula 624 can pierce the portion of the patient. In other embodiments,the cannula assembly 620 can include a trocar (not shown) to facilitatethe insertion of the cannula 624. As described above, the cannulaassembly 620 is physically and fluidically coupled to the port 605 ofthe housing 601 such that when the cannula 624 is placed in fluidcommunication with the vein of the patient, the port 605 is concurrentlyplaced in fluid communication with the vein. With the port 605 in fluidcommunication with the portion of the patient (e.g., the vein), a user(e.g., a physician, nurse, technician, or the like) can engage theengagement portion 645 of the flow control mechanism 640 to place thetransfer device 600 in the second configuration.

As shown in FIG. 29, the transfer device 600 is placed in the secondconfiguration when the plunger portion 650 of the flow control mechanism640 is moved within the fluid reservoir 630 from a first position (e.g.,a distal position) to a proximal position (e.g., a proximal position),as indicated by the arrow PP. More specifically, the transfer device 600includes a spring 649 configured to engage the protrusion 604 of thehousing 601 and the flange 634 of the fluid reservoir 630 to maintainthe fluid reservoir 630 in the first position while the flow controlmechanism 640 is moved to its second position. Similarly, stated theflow control mechanism 640 is moved in a proximal direction relative tothe fluid reservoir 630.

In addition, the first seal member 658 can engage an inner surface ofthe fluid reservoir 630 such that the proximal movement of the flowcontrol mechanism 640 produces a negative pressure within a portion ofthe inner volume 633 of the fluid reservoir 630 (e.g., the portion ofthe inner volume 633 that is disposed distally relative to the firstseal member 658). In this manner, the negative pressure introduces asuction force that can be operable placing the valve 639 in an openconfiguration. Thus, with the cannula 624 and the port 605 in fluidcommunication with the portion of the patient (e.g., the vein), a flowof bodily fluid (e.g., blood) can pass through the valve 639 and enterthe inner volume 633 of the fluid reservoir 630, as indicated by thearrow QQ.

As shown in FIG. 29, the proximal movement of the flow control mechanism640 relative to the fluid reservoir 630 is configured to stop when theflow control mechanism 640 is in the second position (e.g., the proximalposition). More specifically, the protrusion 635 of the fluid reservoir630 can engage the protrusion 653 of the plunger portion 650 to limitthe proximal movement of the flow control mechanism 640 relative to thefluid reservoir 630. Furthermore, when the flow control mechanism 640 isin the second position relative to the fluid reservoir 630, the openings657 of the plunger portion 650 are in fluid communication with theopenings 636 defined by the fluid reservoir 630. Thus, the inner volume656 defined by the plunger portion 650 of the flow control mechanism 640is placed in fluid communication with the inner volume 611 of thehousing 601, as described in further detail herein.

With the transfer device 600 in the second configuration, a flow of apredetermined amount of bodily fluid can be transferred to the innervolume 633 of the fluid reservoir 630 that can include, for example,dermally residing microbes dislodged during a venipuncture event (e.g.,the insertion of the cannula 624 into the vein and/or otherwiseaccessing the vasculature of the patient). In addition, when thepredetermined amount of bodily fluid is transferred to the inner volume633 of the fluid reservoir 630, the valve 639 can be placed in a closedconfiguration. For example, in some embodiments, the transfer of thepredetermined amount of bodily fluid can be such that the negativepressure within the inner volume 633 is brought into equilibrium withthe pressure of the vein, thus allowing the valve 639 to move to theclosed configuration. In other embodiments, the valve 639 can bemanually actuated by user interference (e.g., engagement of an actuator,a switch, a button, a toggle, or the like). In this manner, the bodilyfluid disposed in the inner volume 633 between the first seal member 658and the distal end portion 632 of the fluid reservoir 630 can befluidically isolated from a volume outside the inner volume 633.Expanding further, the first seal member 658 prevents a flow of thebodily fluid in the proximal direction and the valve 639, being in theclosed configuration, prevents a flow of the bodily fluid in the distaldirection. Thus, the predetermined amount of bodily fluid is fluidicallyisolated from a volume outside the inner volume 633 of the fluidreservoir 630 defined between the first seal member 658 and the distalend portion 632.

As indicated by the arrow RR in FIG. 30, the user can continue to movethe flow control mechanism 640 in the proximal direction to place thetransfer device 600 in the third configuration. More specifically, withthe protrusion 653 of the flow control mechanism 640 in contact with theprotrusion 635 of the fluid reservoir 630, the proximal movement of theflow control mechanism 640 is such that the flow control mechanism 640and the fluid reservoir 630 move, concurrently, in the proximaldirection relative to the housing 601. Furthermore, the proximalmovement is such that the valve seat 637 is moved in the proximaldirection relative to the reservoir seat 618. Similarly stated, theproximal movement of the fluid reservoir 630 is such that the valve seat637 is no longer disposed about the reservoir seat 618 of the housing601. In this manner, the port 605 is placed in fluid communication withthe inner volume 611 of the housing 601.

With the transfer device 600 in the third configuration, an externalfluid source (not shown in FIG. 30) can be placed in fluid communicationwith a portion of the transfer device 600 to transfer a flow ofparenteral fluid to the portion of the patient. For example, in someembodiments, the transfer device 600 can include a proximal lockmechanism 613 that can physically and fluidically couple the transferdevice 600 to the external fluid source. The proximal lock mechanism 613can be any of those described herein. In this manner, the external fluidsource can deliver a flow of parenteral fluid to the lumen 646, asindicated by the arrow SS. Moreover, with the lumen 646 in fluidcommunication with the inner volume 656 defined between the firstsurface 652 and the second surface 655, the flow of the parenteral fluidcan pass through the openings 657 defined by the plunger portion 650 ofthe flow control mechanism 640. In addition, the first seal member 658and the second seal member 659 can act to define a fluid flow path thatdirects the flow of the parenteral fluid to the openings 636 defined bythe fluid reservoir 630. In this manner, the flow of parenteral fluidcan pass through the openings 636 of the fluid reservoir 630 to enterthe inner volume 611 defined by the housing 601. Similarly stated, uponexiting the openings 636, the parenteral fluid can flow within the innervolume 611 defined by the housing 601 and outside of the fluid reservoir630, as indicated by the arrows SS. Expanding further, the parenteralfluid can flow within the housing 601 in the distal direction and enterthe port 605 to transfer the flow parenteral fluid to the cannulaassembly 620. Therefore, the external fluid source can deliver a flow ofparenteral fluid to the patient that is fluidically isolated from thepredetermined amount of bodily fluid disposed in the fluid reservoir 630and is thus, substantially free from dermally residing microbes and/orother undesirable external contaminants.

In some embodiments, user intervention maintains the transfer device 600in the third configuration. Expanding further and as described above,the proximal movement of the fluid reservoir 630 is such that a portionof the force applied by the user (e.g., the physician, nurse,technician, or the like) to move the flow control mechanism 640 andfluid reservoir 630 is used to move the spring 649 to a compressedconfiguration. In such embodiments, the removal of the portion of theforce would allow the spring 649 to expand and thereby move the fluidreservoir 630 in the distal direction. In other embodiments, a transferdevice can include a catch, protrusion, latch or the like configured tomaintain the spring in the compressed configuration.

While the transfer device 600 is shown in FIGS. 24-30 as including afluid reservoir 630, in other embodiments, a transfer device can includea flow control mechanism with an integrated fluid reservoir. Forexample, FIGS. 31-34 illustrate a transfer device 700 according to anembodiment. The transfer device 700 includes a housing 701, a cannulaassembly 720, and a flow control mechanism 740. In use, the transferdevice 700 can be moved between a first configuration and a secondconfiguration to receive a predetermined amount of a bodily fluid from apatient and to deliver a flow of a parenteral fluid to the patient thatis substantially free from, for example, dermally residing microbesand/or other undesirable external contaminants.

As shown in FIGS. 31 and 32, the housing 701 includes a proximal endportion 702 having a proximal port 706 and a distal end portion 703having a distal port 705. The proximal port 706 is configured to bephysically and fluidically coupled to an external fluid source, asdescribed in further detail herein. The distal port 705 is configured tobe physically and fluidically coupled to a lock mechanism 721 includedin the cannula assembly 720. For example, in some embodiments, the lockmechanism 721 can be a Luer-Lok® configured to receive the distal port705. In other embodiments, the distal port 705 and the lock mechanism721 can be coupled in any suitable manner such as, for example, athreaded coupling, a friction fit, or the like. In still otherembodiments, the distal port 705 and the lock mechanism 721 can becoupled via an adhesive or the like to fixedly couple the cannulaassembly 720 to the housing 701. With the lock mechanism 721 coupled tothe distal port 705, the distal port 705 is placed in fluidcommunication with a cannula 724 included in the cannula assembly 720,as further described herein.

The housing 701 defines an inner volume 711 and a set of recess 710. Theinner volume 711 is configured to receive at least a portion of the flowcontrol mechanism 740. As shown in FIG. 31, the set of recesses 710 aredefined by the housing 701 in a perpendicular orientation relative tothe proximal port 706 and distal port 705. Similarly stated, therecesses 710 are perpendicular to a centerline defined by the proximalport 706 and the distal port 705. In this manner, a portion of the flowcontrol mechanism 740 can extend through the recesses 710 when the flowcontrol mechanism 740 is disposed within the inner volume 711 of thehousing 701, as described in further detail herein.

The flow control mechanism 740 defines a first lumen 746, a second lumen747, and a fluid reservoir 730. The first lumen 746 extends through aportion of the flow control mechanism 740 and is in fluid communicationwith the fluid reservoir 730. Similarly stated, the first lumen 746extends through a portion of the flow control mechanism 740 toselectively place the fluid reservoir 730 in fluid communication with avolume substantially outside of the flow control mechanism 740, asdescribed in further detail herein. As shown in FIG. 33, the secondlumen 747 extends through the flow control mechanism 740 and isfluidically isolated from the fluid reservoir 730. In this manner, thesecond lumen 747 can be selectively placed in fluid communication withthe proximal port 706 and the distal port 705 of the housing 701 todeliver a flow of parenteral fluid, as described in further detailherein.

The flow control mechanism 740 has a circular cross-sectional shape suchthat when the flow control mechanism 740 is disposed within the innervolume 711, a portion of the flow control mechanism 740 forms a frictionfit with the walls of the housing 701 defining the inner volume 711. Forexample, in some embodiments, the flow control mechanism 740 is formedfrom silicone and has a diameter larger than the diameter of the innervolume 711. In this manner, the diameter of the flow control mechanism740 is reduced when the flow control mechanism 740 is disposed withinthe inner volume 711. Thus, the outer surface of the flow controlmechanism 740 forms a friction fit with the inner surface of the wallsdefining the inner volume 711. In other embodiments, the flow controlmechanism 740 can be any suitable elastomer configured to deform whendisposed within the inner volume 711 of the housing 701.

In use, while in the first configuration, the cannula 724 of the cannulaassembly 720 can be inserted into a portion of a patient to place thecannula 724 in fluid communication with, for example, a vein. In someembodiments, the cannula 724 can include a sharp point at a distal endsuch that the cannula 724 can pierce the portion of the patient. Inother embodiments, the cannula assembly 720 can include a trocar (notshown) to facilitate the insertion of the cannula 724. As describedabove, the cannula assembly 720 is physically and fluidically coupled tothe distal port 705 of the housing 701 such that when the cannula 724 isplaced in fluid communication with the vein of the patient, the distalport 705 is placed in fluid communication with the vein.

As shown in FIG. 33, when the transfer device 700 is in the firstconfiguration, the first lumen 746 of the flow control mechanism 740 isin fluid communication with the distal port 705 of the housing 701. Inthis manner, the fluid reservoir 730 defined by the flow controlmechanism 740 is placed in fluid communication with the vein of thepatient and can receive a flow of a bodily fluid (e.g., blood).Moreover, with the flow control mechanism 740 forming a friction fitwith the inner surface of the housing 701 (as described above), the flowcontrol mechanism 740 and the housing 701 can form a substantially fluidtight seal about an inlet of the first lumen 746. In this manner, thecannula assembly 720, the distal port 705, and the first lumen 746collectively define a flow path configured to deliver a flow of bodilyfluid from the portion of the patient to the fluid reservoir 730, asindicated by the arrow TT. In addition, the flow of bodily fluid can besuch that dermally residing microbes dislodged during a venipunctureevent (e.g., the insertion of the cannula 724) are entrained in the flowof bodily fluid and are transferred to the fluid reservoir 740.

With a desired amount of bodily fluid transferred to the fluid reservoir730, a user can engage the transfer device 700 to move the transferdevice 700 from the first configuration to the second configuration. Insome embodiments, the desired amount of bodily fluid transferred to thefluid reservoir 730 is a predetermined amount of fluid. For example, insome embodiments, the transfer device 700 can be configured to transferbodily fluid until the pressure within the fluid reservoir 730 isequilibrium with the pressure of the portion of the body in which thecannula 724 is disposed (e.g., the vein). In some embodiments, at leasta portion of the flow control mechanism 740 can be transparent to allowvisualization of the bodily fluid flowing into the fluid reservoir 730.The flow control mechanism 740 can include indicators (e.g., 0.1 mL, 0.5mL, 1 mL, 1.5 mL, 2 mL, 3 mL, 4 mL, 5 mL, etc. graduation marks) to theuser can visualize the volume of bodily fluid that has been received inthe fluid reservoir 730.

As shown in FIG. 34, the transfer device 700 can be moved from the firstconfiguration to the second configuration by moving the flow controlmechanism 740 in the direction of the arrow UU. In this manner, thefirst lumen 746 is fluidically isolated from the distal port 705. Whilenot shown in FIGS. 31-34, the first lumen 746 can include a valve orseal configured to fluidically isolate the bodily fluid disposed withinthe fluid reservoir 730 from a volume outside the flow control mechanism740. In some embodiments, the valve can be, for example, a one-way checkvalve. Thus, the fluid reservoir 730 can receive the flow of fluid froma volume outside the fluid reservoir 730 but prevent a flow of fluidfrom the fluid reservoir 730.

When moved to the second configuration, the second lumen 747 defined bythe flow control mechanism 740 is placed in fluid communication with thedistal port 705 and the proximal port 706 of the housing 701. Asdescribed above, the proximal port 706 can be physically and fluidicallycoupled to an external fluid source (not shown in FIGS. 31-34) such thatwhen the transfer device 700 is in the second configuration, theproximal port 706, the second lumen 747, the distal port 705, and thecannula assembly 720 collectively define a fluid flow path. In thismanner, the transfer device 700 can facilitate the delivery of a flow ofparenteral fluid from the external fluid source to the portion of thepatient (e.g., the vein), as indicated by the arrow VV in FIG. 34.Expanding further, with the predetermined amount of bodily fluidfluidically isolated within the fluid reservoir 730, the transfer device700 can facilitate the delivery of the flow of parenteral fluid to thepatient that is substantially free from, for example, the dermallyresiding microbes dislodged during the venipuncture event.

While the flow control mechanism 740 is shown in FIGS. 31-34 asincluding the integrated fluid reservoir 730, in other embodiments, atransfer device can be configured to be physically and fluidicallycoupled to an external fluid reservoir. For example, FIGS. 35-39illustrate a transfer device 800 according to an embodiment. As shown inFIGS. 35 and 36, the transfer device 800 includes a housing 801, acannula assembly 820, and a flow control mechanism 880. In use, thetransfer device 800 can be moved between a first configuration and asecond configuration to receive a predetermined amount of a bodily fluidfrom a patient and to deliver a flow of a parenteral fluid to thepatient that is substantially free from, for example, dermally residingmicrobes.

The housing 801 includes a proximal end portion 802, a distal endportion 803, and defines an inner volume 811. The inner volume 811 canreceive at least a portion of the flow control mechanism 880 and theactuator 880, as further described herein. As shown in FIG. 37, thedistal end portion 803 of the housing 801 defines a distal port 805 andthe proximal end portion 802 of the housing 801 defines a first proximalport 806, and a second proximal port 807. The distal port 805, the firstproximal port 806, and the second proximal port 807 are configured to bein fluid communication with the inner volume 811 defined by the housing801.

The distal port 805 is configured to receive a distal cannula 817. Thedistal cannula 817 (e.g., a lumen defining cannula) is configured to bephysically and fluidically coupled to a port 822 included in the cannulaassembly 820. The port 822 can be any suitable port. For example, insome embodiments, the distal cannula 817 and the port 822 can be coupledvia an adhesive or the like to fixedly couple the cannula assembly 820to the housing 801. With the port 822 of the cannula assembly 820coupled to the distal cannula 817 and with the distal cannula 817coupled to the distal port 805, the distal port 805 is in fluidcommunication with a cannula 824 included in the cannula assembly 820,as further described herein.

The first proximal port 806 and the second proximal port 807 areconfigured to receive a first proximal cannula 812 and a second proximalcannula 814, respectively (e.g., lumen defining cannulas). Furthermore,the first proximal cannula 812 is physically and fluidically coupled toa first lock mechanism 813 that can further be physically andfluidically coupled to an external fluid reservoir (not shown in FIGS.35-39). Similarly, the second proximal cannula 814 is physically andfluidically coupled to a second lock mechanism 815 that can further bephysically and fluidically coupled to an external fluid source (notshown in FIGS. 35-39). In this manner, the cannula assembly 820, theexternal fluid reservoir (not shown), and the external fluid source (notshown) can be selectively placed in fluid communication with the innervolume 811 defined by the housing 801, as described in further detailherein.

Referring back to FIG. 36, the actuator mechanism 880 includes anengagement portion 882 and an activation surface 884. The activationsurface 844 is configured to contact, mate, or otherwise engage the flowcontrol mechanism 840. The engagement portion 882 can be engaged by auser to rotate the actuator mechanism 880 relative to the housing 801 tomove the transfer device 800 between a first configuration and a secondconfiguration, as described in further detail herein.

The flow control mechanism 840 defines a first lumen 846 and a secondlumen 847 and is disposed within the inner volume 821 defined by thehousing 801. The flow control mechanism 840 defines a circularcross-sectional shape such that when the flow control mechanism 840 isdisposed within the inner volume 821, a portion of the flow controlmechanism 840 forms a friction fit with the walls of the housing 801defining the inner volume 821, as described in detail above. The flowcontrol mechanism 840 is operably coupled to and/or otherwise engagesthe actuator 880. For example, in some embodiments, the actuatormechanism 880 can be coupled to the flow control mechanism 840 via amechanical fastener and/or adhesive. In other embodiments, the actuatormechanism 880 and the flow control mechanism 840 can be coupled in anysuitable manner. Therefore, the flow control mechanism 840 is configuredto move concurrently with the actuator mechanism 880 when the actuatormechanism 880 is rotated relative to the housing 801. In this manner,the flow control mechanism 840 can be moved to place the first lumen 846or the second lumen 847 in fluid communication with the distal port 805,the first proximal port 806, and/or the second proximal port 807, asdescribed in further detail herein.

In use, while in the first configuration, the cannula 824 of the cannulaassembly 820 can be inserted into a portion of a patient to place thecannula 824 in fluid communication with, for example, a vein. In someembodiments, the cannula 824 can include a sharp point at a distal endsuch that the cannula 824 can pierce the portion of the patient. Inother embodiments, the cannula assembly 820 can include a trocar (notshown) to facilitate the insertion of the cannula 824. As describedabove, the cannula assembly 820 is physically and fluidically coupled tothe distal port 805 of the housing 801 such that when the cannula 824 isplaced in fluid communication with the vein of the patient, the distalport 805 is placed in fluid communication with the vein.

Furthermore, a user (e.g., a physician, a nurse, a technician, or thelike) can engage the transfer device 800 to physically and fluidicallycouple the first lock mechanism 813 to an external fluid reservoir (notshown). The external fluid reservoir can be any suitable reservoir. Forexample, in some embodiments, the external fluid reservoir can be aBacT/ALERT® SN or a BacT/ALERT® FA, manufactured by BIOMERIEUX, INC. Inthis manner, the external fluid reservoir can define a negative pressurewithin an inner volume of the reservoir. Therefore, when the flowcontrol mechanism 840 is in the first configuration, a negative pressuredifferential introduces a suction force within the first proximalcannula 812, the first lumen 846 defined by the flow control mechanism840, the distal cannula 817, and the cannula assembly 820. In thismanner, the first proximal cannula 812, the first lumen 846 defined bythe flow control mechanism 840, the distal cannula 817, and the cannulaassembly 820 collectively define a fluid flow path configured totransfer a flow of a bodily fluid to the external fluid reservoir, asindicated by the arrow WW in FIG. 37. In addition, the flow of bodilyfluid can be such that dermally residing microbes dislodged during avenipuncture event (e.g., the insertion of the cannula 824) areentrained in the flow of bodily fluid and are transferred to theexternal fluid reservoir.

As shown in FIG. 38, in some embodiments, the magnitude of the suctionforce can be modulated by moving the actuator mechanism 880 in thedirection of the arrow XX. For example, in some instances, it can bedesirable to limit the amount of suction force introduced to a vein. Insuch instances, the user can move the actuator mechanism 880 and theflow control mechanism 840 to reduce the size of the fluid pathway(e.g., an inner diameter) between the distal port 805 of the housing 801and the first lumen 846 of the flow control mechanism 840, therebyreducing the suction force introduced into the vein of the patient.

With the desired amount of bodily fluid transferred to the externalfluid reservoir, a user can engage the actuator mechanism 880 to movethe transfer device 800 from the first configuration to the secondconfiguration. In some embodiments, the desired amount of bodily fluidtransferred to the external fluid reservoir is a predetermined amount offluid. For example, in some embodiments, the transfer device 800 can beconfigured to transfer bodily fluid until the pressure within theexternal fluid reservoir is equilibrium with the pressure of the portionof the body in which the lumen-defining device is disposed (e.g., thevein), as described above. In some embodiments, at least a portion ofthe external fluid reservoir can be transparent to allow visualizationof the bodily fluid flowing into the fluid reservoir. The external fluidreservoir can include indicators (e.g., 0.1 mL, 0.5 mL, 1 mL, 1.5 mL, 2mL, 3 mL, 4 mL, 5 mL, etc. graduation marks to accommodateidentification of diversion volumes ranging from just a few drops orcentiliters of blood to a larger volumes) so the user can visualize thevolume of bodily fluid that has been received in the external fluidreservoir.

The transfer device 800 can be moved from the first configuration to thesecond configuration by further moving the actuator mechanism 880 in thedirection of the arrow XX in FIG. 38. As the actuator mechanism 880 ismoved from the first configuration toward the second configuration, theactuator mechanism 880 rotates the flow control mechanism 840 toward itssecond configuration. In this manner, the first lumen 846 is fluidicallyisolated from the distal port 805 and the first proximal port 806 andthe external fluid reservoir can be physically and fluidically decoupledfrom the transfer device 800. In addition, the second lumen 847 definedby the flow control mechanism 840 is placed in fluid communication withthe distal port 805 and the second proximal port 807, as shown in FIG.39.

With the transfer device in the second configuration, the secondproximal lock mechanism 815 can be physically and fluidically coupled tothe external fluid source (not shown in FIGS. 35-39). In this manner,the second proximal cannula 814, the second lumen 847 of the flowcontrol mechanism 840, the distal cannula 817, and the cannula assembly820 collectively define a fluid flow path. Thus, the transfer device 800can facilitate the delivery of a flow of parenteral fluid from theexternal fluid source to the portion of the patient (e.g., the vein), asindicated by the arrow YY in FIG. 39. Expanding further, with thepredetermined amount of bodily fluid transfer to the external fluidreservoir and with the external fluid reservoir decoupled from thetransfer device 800, the transfer device 800 can facilitate the deliveryof the flow of parenteral fluid to the patient that is substantiallyfree from, for example, the dermally residing microbes dislodged duringthe venipuncture event or otherwise introduced to the fluid flow path tothe patient.

FIG. 40 is a flowchart illustrating a method 990 of delivering a fluidto a patient using a fluid transfer device, according to an embodiment.The method 990 includes establishing fluid communication between thepatient and the fluid transfer device, at 991. The fluid transfer devicecan be any of those described herein. As such, the fluid transfer devicecan include a cannula assembly or the like that can be insertedpercutaneously to place the fluid transfer device in fluid communicationwith the patient (e.g., inserted into a vein of the patient). Morespecifically, in some embodiments, the cannula assembly of the fluidtransfer device can include a sharpened distal end configured to piercethe skin of the patient. In other embodiments, the transfer device caninclude a flow control mechanism that can include a sharpened distal endportion that is configured to extend beyond a distal end portion of thecannula assembly to pierce the skin of the patient. For example, in someembodiments, the fluid transfer device can include a flow controlmechanism that is substantially similar to the flow control mechanism340 of the transfer device 300 described above with reference to FIGS.4-10.

With the cannula assembly in fluid communication with the patient, apredetermined volume of a bodily fluid is withdrawn from the patient, at991. For example, in some embodiments, the fluid transfer device caninclude a flow control mechanism, such as those described above, thatcan be moved between a first configuration and a second configuration.In some embodiments, flow control mechanism can be configured to definea fluid flow path between, for example, the cannula assembly and a fluidreservoir included in and/or fluidically coupled to the fluid transferdevice. In other embodiments, any portion of fluid transfer device candefine at least a portion of the fluid flow path. For example, the fluidtransfer device can include a housing or the like that can define atleast a portion of the fluid flow path. Thus, the predetermined volumeof the bodily fluid is transferred to the fluid reservoir, at 993. Insome embodiments, the predetermined volume of the bodily fluid caninclude, for example, dermally residing microbes that were dislodgedduring, for example, the venipuncture event (e.g., inserting the cannulaassembly into the patient).

Once the predetermined volume of bodily fluid is disposed in the fluidreservoir, the fluid transfer device is fluidically isolated from thefluid reservoir to sequester the predetermined volume of bodily fluid inthe fluid reservoir, at 994. For example, in some embodiments, once thepredetermined volume of bodily fluid is disposed in the fluid reservoir,the fluid transfer device can be physically and/or fluidically decoupledfrom the fluid reservoir. In other embodiments, the flow controlmechanism (as described above) can be moved from the first configurationto the second configuration to fluidically isolate the fluid reservoirfrom a volume outside of the fluid reservoir. For example, in someembodiments, the flow control mechanism can define a lumen or the likethat can define a fluid flow path between the cannula assembly and thefluid reservoir when in the first configuration. In such embodiments,the flow control mechanism can be transitioned (e.g., moved, rotated,and/or otherwise reconfigured) from the first configuration to thesecond configuration in which the lumen is removed from fluidcommunication with the cannula assembly and/or the fluid reservoir,thereby fluidically isolating the fluid reservoir from the cannulaassembly. In some embodiments, the flow control mechanism can beconfigured to transition from the first configuration to the secondconfiguration automatically once the predetermined volume of bodilyfluid is disposed in the fluid reservoir.

With the fluid reservoir fluidically isolated from at least a portion ofthe fluid transfer device, fluid communication is established betweenthe patient and a fluid source via the fluid transfer device, at 995.For example, in some embodiments, the fluid source can be operablycoupled to the fluid transfer device to place the fluid source in fluidcommunication with at least a portion of the fluid transfer device. Insome embodiments, the flow control mechanism (described above) candefine a second lumen that can place the fluid source in fluidcommunication with the cannula assembly when in the secondconfiguration. In other embodiments, with the fluid reservoir decoupledfrom the fluid transfer device that fluid source can be placed in fluidcommunication with the cannula assembly via any other portion of thefluid transfer device (e.g., a portion of a housing and/or the like). Inthis manner, a fluid can flow from the fluid source, through the fluidtransfer device and into the patient. Moreover, by fluidically isolatingthe predetermined volume of bodily fluid the flow of fluid from thefluid source can be substantially free of contaminants such as, forexample, the dermally residing microbes, as described above.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where methods and steps described above indicate certainevents occurring in certain order, those of ordinary skill in the arthaving the benefit of this disclosure would recognize that the orderingof certain steps may be modified and that such modifications are inaccordance with the variations of the invention. Additionally, certainof the steps may be performed concurrently in a parallel process whenpossible, as well as performed sequentially as described above.Additionally, certain steps may be partially completed before proceedingto subsequent steps.

While various embodiments have been particularly shown and described,various changes in form and details may be made. For example, while theactuator 580 is shown and described with respect to FIG. 21 as beingrotated in a single direction, in other embodiments, an actuator can berotated in a first direction (e.g., in the direction of the arrow MM inFIG. 21) and a second direction, opposite the first. In suchembodiments, the rotation in the second direction can be configured tomove a transfer device through any number of configurations. In otherembodiments, the rotation of the actuator in the second direction can belimited.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having any combination or sub-combination of any featuresand/or components from any of the embodiments described herein.

The specific configurations of the various components can also bevaried. For example, the size and specific shape of the variouscomponents can be different from the embodiments shown, while stillproviding the functions as described herein. More specifically, the sizeand shape of the various components can be specifically selected for adesired rate of bodily fluid flow into a fluid reservoir or for adesired rate of parenteral fluid flow into the patient.

The invention claimed is:
 1. An apparatus, comprising: a cannulaassembly; a housing including a proximal end portion and a distal endportion and defining an inner volume therebetween, the housing having aninlet port configured to be removably coupled to the cannula assembly; afluid reservoir coupled to the housing and configured to move from afirst configuration to a second configuration to create a negativepressure in the fluid reservoir, the fluid reservoir configured toreceive and isolate a first volume of bodily fluid withdrawn from thepatient; a flow control mechanism at least partially disposed in theinner volume of the housing and configured to move relative to thehousing between a first configuration and a second configuration, theflow control mechanism defining a fluid flow path between the cannulaassembly and the fluid reservoir in the first configuration; and anactuator operably coupled to the flow control mechanism and configuredto move the flow control mechanism from the first configuration in whichthe inlet port is placed in fluid communication with the fluid reservoirsuch that bodily fluid can flow from the cannula assembly, through theinlet port via the fluid flow path and to the fluid reservoir inresponse to the negative pressure, to the second configuration, in whichthe fluid reservoir is fluidically isolated from the cannula assembly.2. The apparatus of claim 1, wherein the flow control mechanism includesa fluid communicator configured to be moved from a first position to asecond position to place the flow control mechanism in the secondconfiguration.
 3. The apparatus of claim 2, wherein the fluidcommunicator is configured to extend through the inlet port and beyondthe distal end portion of the housing in the first position.
 4. Theapparatus of claim 2, wherein the fluid communicator is configured to beretracted into the inner volume of the housing in the second position.5. The apparatus of claim 1, wherein the flow control mechanism includesa first member movably disposed in the inner volume of the housing, anda second member coupled to the first member and configured to extendthrough the inlet port and beyond the distal end portion of the housingin the first configuration.
 6. The apparatus of claim 5, wherein thefirst member includes a proximal end portion and a distal end portion,and defines a lumen therethrough.
 7. The apparatus of claim 6, whereinthe second member includes a proximal end portion and a distal endportion, and defines a lumen therethrough.
 8. The apparatus of claim 7,wherein the proximal end portion of the second member is configured tobe disposed in the lumen defined by the first member.
 9. The apparatusof claim 7, wherein the distal end portion of the second member isconfigured to extend beyond a distal end of the cannula assembly whenthe flow control mechanism is in the first configuration.
 10. Theapparatus of claim 1, wherein the flow control mechanism includes aspring configured to expand and move the flow control mechanism from thefirst configuration to the second configuration.
 11. The apparatus ofclaim 10, wherein the actuator is configured to release the spring froma compressed state when actuated by a user.
 12. The apparatus of claim1, wherein the movement of the fluid reservoir from the firstconfiguration to the second configuration results in an increase in avolume of the fluid reservoir, the increase in the volume of the fluidreservoir configured to create the negative pressure in the fluidreservoir.
 13. The apparatus of claim 1, wherein the fluid reservoirincludes a proximal end portion and a distal end portion and defines aninner volume therebetween, the inner volume configured to selectivelyreceive at least a portion of the flow control mechanism.
 14. Theapparatus of claim 1, wherein the fluid reservoir is moved relative tothe housing from a first position to a second position to move the fluidreservoir from the first configuration to the second configuration. 15.An apparatus, comprising: a cannula assembly; a housing including aproximal end portion and a distal end portion and defining an innervolume therebetween, the housing having an inlet port configured to beremovably coupled to the cannula assembly; a fluid reservoir coupled tothe housing and configured to move from a first position to a secondposition to create a negative pressure within the fluid reservoir, thefluid reservoir configured to receive and isolate a first volume ofbodily fluid withdrawn from the patient; a flow control mechanism atleast partially disposed in the inner volume of the housing andconfigured to move relative to the housing between a first configurationand a second configuration, the flow control mechanism defining a fluidflow path between the cannula assembly and the fluid reservoir in thefirst configuration; and an actuator operably coupled to the flowcontrol mechanism and configured to move the flow control mechanism fromthe first configuration in which the inlet port is placed in fluidcommunication with the fluid reservoir such that bodily fluid can flowfrom the cannula assembly, through the inlet port via the fluid flowpath and to the fluid reservoir in response to the negative pressure, tothe second configuration, in which the fluid reservoir is fluidicallyisolated from the cannula assembly.
 16. The apparatus of claim 15,wherein the flow control mechanism includes a fluid communicatorconfigured to be moved from a first position to a second position toplace the flow control mechanism in the second configuration.
 17. Theapparatus of claim 16, wherein the fluid communicator is configured toextend through the inlet port and beyond the distal end portion of thehousing in the first position.
 18. The apparatus of claim 16, whereinthe fluid communicator is configured to be retracted into the innervolume of the housing in the second position.
 19. The apparatus of claim15, wherein the flow control mechanism includes a first member movablydisposed in the inner volume of the housing, and a second member coupledto the first member and configured to extend through the inlet port andbeyond the distal end portion of the housing in the first configuration.20. The apparatus of claim 19, wherein the first member includes aproximal end portion and a distal end portion, and defines a lumentherethrough.
 21. The apparatus of claim 20, wherein the second memberincludes a proximal end portion and a distal end portion, and defines alumen therethrough.
 22. The apparatus of claim 21, wherein the proximalend portion of the second member is configured to be disposed in thelumen defined by the first member.
 23. The apparatus of claim 21,wherein the distal end portion of the second member is configured toextend beyond a distal end of the cannula assembly when the flow controlmechanism is in the first configuration.
 24. The apparatus of claim 15,wherein the flow control mechanism includes a spring configured toexpand and move the flow control mechanism from the first configurationto the second configuration.
 25. The apparatus of claim 24, wherein theactuator is configured to release the spring from a compressed statewhen actuated by a user.
 26. The apparatus of claim 15, wherein thefluid reservoir includes a proximal end portion and a distal end portionand defines an inner volume therebetween, the inner volume configured toselectively receive at least a portion of the flow control mechanism.27. The apparatus of claim 15, wherein the fluid reservoir is movedrelative to the housing from the first position to the second positionto move the fluid reservoir from a first configuration to a secondconfiguration.